prEN ISO 15193

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

DOW = DAV + 36 months

In‑vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO/DIS 15193:2023)

Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence (ISO/DIS 15193:2023)

Diagnostični medicinski pripomočki in vitro - Zahteve za referenčne merilne postopke (ISO/DIS 15193:2023)

General Information

• Status: Not Published
• Publication Date: 19-Mar-2025
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 3 - Quality management in the medical laboratory
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 18-Jul-2024
• Completion Date: 18-Jul-2024
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: oSIST prEN ISO 15193:2024 - In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

Relations

• Revises: EN ISO 15193:2009 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
• Effective Date: 10-Mar-2021

prEN ISO 15193 - Overview

Standard reference: prEN ISO 15193 (ISO/DIS 15193:2023)
Title: In vitro diagnostic medical devices - Requirements for reference measurement procedures
Organization: CEN / ISO (ISO/TC 212) - Draft international standard (ISO/CEN parallel processing)

This draft standard defines the required content and presentation of reference measurement procedures used for in vitro diagnostic (IVD) medical devices. It replaces and updates the earlier ISO 15193:2009 edition and is intended to support traceable, reproducible and well‑documented reference methods for clinical laboratory testing and IVD device evaluation.

Key topics and technical requirements

prEN ISO 15193 sets out structured requirements for the design, documentation and validation of reference measurement procedures. Major topics include:

• Scope and terminology
  • Clear definition of purpose, measurement concepts, nomenclature and trivial names.
• Measurement principle and method
  • Description of the analytical principle and stepwise measurement method.
• Reagents, materials and consumables
  • Required descriptive information, influence quantities and references to patented items.
• Apparatus, equipment and sampling
  • Detailed description of instruments, auxiliary equipment, sample types and sampling procedure.
• Preparation and operation
  • Preparation of the measuring system, calibration, analytical series design and operating sequence.
• Data processing and reporting
  • Calculation, conversion equations and standardized reporting of measurement results.
• Validation and performance characteristics
  • Requirements for calibration/analytical calibration function, sensitivity, precision (repeatability, intermediate precision, reproducibility), trueness, limit of detection, measurement interval and uncertainty estimation.
• Quality assurance and interlaboratory considerations
  • Use of reference materials, interlaboratory comparisons and ongoing QA practices.
• Annexes
  • Includes informative annexes such as relationship to EU Regulation (EU) 2017/746 (Annex ZA).

Practical applications and users

This standard is relevant to organizations and professionals involved in IVD reference methods and clinical measurement metrology:

• Clinical and national reference laboratories developing or publishing reference procedures.
• IVD manufacturers documenting reference or calibration methods for device validation.
• Regulatory authorities and notified bodies assessing conformity with regulatory requirements (e.g., EU MDR/IVDR).
• Metrology institutes, standardization bodies and proficiency testing providers.
• Test developers who require robust validation, traceability and measurement uncertainty documentation.

Adoption of ISO 15193 improves method transparency, comparability of results across laboratories, and supports regulatory compliance and clinical decision quality.

Related standards

• ISO 15189 (medical laboratories - competence and quality)
• International guidelines on measurement uncertainty and reference materials
• EU Regulation (EU) 2017/746 (IVDR) - Annex ZA links this standard to regulatory requirements

Keywords: ISO 15193, in vitro diagnostic, reference measurement procedures, IVD, validation, calibration, measurement uncertainty, clinical laboratories, reference laboratory, IVDR.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2024
Diagnostični medicinski pripomočki in vitro - Zahteve za predstavitev referenčnih
merilnih postopkov (ISO/DIS 15193:2023)
In vitro diagnostic medical devices - Requirements for reference measurement
procedures (ISO/DIS 15193:2023)
In‑vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO/DIS 15193:2023)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des
échantillons d'origine biologique - Exigences relatives au contenu et à la présentation
des procédures de mesure de référence (ISO/DIS 15193:2023)
Ta slovenski standard je istoveten z: prEN ISO 15193
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-12-26 2024-03-19
In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:

In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for a reference measurement procedure .10
4.1 General . 10
4.2 Elements of a reference measurement procedure . 10
4.3 Warning and safety precautions . 11
4.4 Introduction . 11
4.5 Scope . .12
4.6 Terms, definitions, symbols, and abbreviated terms .12
4.6.1 Concepts .12
4.6.2 Nomenclature . 12
4.6.3 Trivial names .12
4.7 Measurement principle and measurement method .12
4.8 Reagents and materials .13
4.8.1 General .13
4.8.2 Descriptive items .13
4.8.3 Influence quantities . 14
4.8.4 Expression of concentration . 14
4.8.5 Expression of dilution . 14
4.8.6 Reference to patented items . 15
4.9 Apparatus and equipment .15
4.9.1 Description .15
4.9.2 Auxiliary equipment .15
4.10 Consumables . . . 15
4.11 Sampling and sample .15
4.11.1 General .15
4.11.2 Samples .15
4.12 Preparation of measuring system and analytical portion . 16
4.12.1 General . 16
4.12.2 Preparation of apparatus . 16
4.12.3 Calibration . . . 16
4.12.4 Types of analytical sample . 16
4.12.5 Design of analytical series . 17
4.12.6 Analytical portion . 17
4.12.7 Analytical solution . 17
4.13 Operation of measuring system . 17
4.13.1 Sequence of measurement steps . 17
4.13.2 Blank . 17
4.13.3 Validation of measurement conditions . 17
4.14 Data processing. 18
4.14.1 Calculation of measurement results . 18
4.14.2 Conversion equations . 18
4.15 Validation . 18
4.15.1 Concepts, values, and their use . . 18
4.15.2 Analytical calibration function . 19
4.15.3 Analytical measurement function . 19
4.15.4 Analytical sensitivity . 19
4.15.5 Analytical influence quantities . 19
4.15.6 Blank measurement . 19
4.15.7 Recovery studies . 19
iii
ISO/DIS 15193:2023(E)
4.15.8 Measurement trueness .20
4.15.9 Measurement precision .20
4.15.10 Repeatability standard deviation, s . 20
r
4.15.11 Intermediate precision standard deviation . 20
4.15.12 Reproducibility standard deviation, s . 20
R
4.15.13 Limit of detection . 20
4.15.14 Measurement interval . 20
4.15.15 Validation by using reference material . 21
4.15.16 Interlaboratory comparison . 21
4.15.17 Measurement uncertainty . 21
4.16 Special cases . 21
4.17 Reporting of measurement results. 22
4.18 Quality assurance . 22
4.19 Bibliography . 22
4.20 Dates of authorization and revision . 22
Annex A (informative) Reference procedures for properties other than differential and
rational quantities .23
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .25
Bibliography .28
iv
ISO/DIS 15193:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity, or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
This third edition cancels and replaces the second edition (ISO 15193:2009), which has been technically
revised.
The main changes are as follows:
— title and chapter headings have been changed to better reflect the objective of the document;
— requirements, concepts and definitions have been incorporated for consistency with ISO 17511:2020,
ISO 15194:XXXX, and ISO 15195:2018;
— content has been adapted to make the document applicable to all types of measurands;
— the subchapters of Chapter 4 "Requirements for a reference measurement procedure" have been
revised and specified in order to present the requirements more transparently;
— subclause 4.1 has been added to emphasize quality requirements for a reference measurement
procedure; and
— aspects of validation have been updated and summarized in Chapter 4.15.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/DIS 15193:2023(E)
Introduction
Reference measurement systems are needed to enable the results produced by end user measurement
procedures to be metrologically traceable to measurement standards and/or measurement procedures
of the highest metrological level. Such systems exist within a traceability chain/calibration hierarchy as
described in ISO 17511:2020. In the context of in vitro diagnostic (IVD) medical devices, they mitigate
the risk of harm to patients by avoiding inconsistent results from different measuring systems.
Reference measurement procedures play a crucial role in this metrological traceability system, because
they can be used for the following:
a) assessing performance properties of measuring systems – comprising measuring instruments,
auxiliary equipment as well as reagents,
b) assessing whether there is a functional interchangeability of different end user measurement
procedures purporting to measure the same quantity,
c) assigning quantity values to reference materials that are then used for purposes of calibration or
measurement trueness control of end user measurement procedures, and
d) detecting analytical influence quantities in biological samples measured using end user
measurement procedures.
For medical laboratory measurements, in particular, it is vitally important to both patient care and
health screening that the measurement results reported by different end user systems be equivalent,
comparable over time, reproducible and accurate. Establishing metrological traceability of an end user
measuring system to a reference measurement procedure enables equivalent results to be reported. It
is advisable that a reference measurement procedure be specified, especially when:
— it is required by e.g. standards, technical specifications, or technical regulations,
— quantity values are to be stated by the manufacturer, and
— technical requirements have a direct relationship to the performance of a product or process.
The advantages of having a standard for reference measurement procedures are listed in the ISO/IEC
Directives, Part 1, 2021, (Annex SM).
In this document, defined concepts are indicated by italicized text.
vi
DRAFT INTERNATIONAL STANDARD ISO/DIS 15193:2023(E)
In vitro diagnostic medical devices — Requirements for
reference measurement procedures
1 Scope
This document specifies requirements for reference measurement procedures for measurands used in
laboratory medicine.
This document applies to
a) reference measurement procedures providing values of differential or rational quantities. Annex A
provides information on nominal properties and ordinal quantities.
b) any person, body or institution developing reference measurement procedures for measurands
used in laboratory medicine.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
me a s ur ement (GUM: 1995)
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and human samples
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO 17511
and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
analyte
component represented in the name of a quantity (3.29)
EXAMPLE In the type of quantity (3.29) "mass of protein in 24-hour urine", "protein" is the analyte. In
“amount of substance of glucose in plasma”, “glucose” is the analyte. In both cases the full phrase describes the
measurand (3.18).
[SOURCE: ISO 17511:2020, 3.1]
3.2
analytical interference
systematic effect on a measurement caused by an influence quantity (3.14) which does not by itself
produce an indication, but which causes an enhancement or depression of the indication
ISO/DIS 15193:2023(E)
3.3
analytical portion
portion of material taken from the analytical sample (3.4) and on which the measurement is actually
carried out, either directly or following dissolution
Note 1 to entry: The analytical portion is taken directly from the primary sample (3.28) or laboratory sample
(3.16) if no preparation of these is required. The analytical portion is sometimes dissolved to give an analytical
solution (3.7) before being exposed to the measuring device.
3.4
analytical sample
sample prepared from the laboratory sample (3.16) and from which analytical portions (3.3) can be
taken
Note 1 to entry: The analytical sample can be subjected to various treatments before an analytical portion (3.3)
is taken.
3.5
analytical selectivity
selectivity of a measuring system
selectivity
property of a measuring system (3.24), used with a specified measurement procedure (3.21), whereby it
provides measured quantity (3.29) values for one or more measurands (3.18) such that the values of each
measurand (3.18) are independent of other measurands (3.18) or other quantities in the phenomenon,
body, or substance being investigated
Note 1 to entry: Adapted from ISO 17511:2020 and ISO/IEC Guide 99:2007.
3.6
analytical sensitivity
quotient of the change in an indication of a measuring system (3.24) and the corresponding change in
the value of a quantity (3.29) being measured
Note 1 to entry: The term analytical sensitivity is not intended to be used as a synonym for detection limit (3.12).
Note 2 to entry: ISO/IEC Guide 99:2007, 4.12 uses the term “sensitivity of a measuring system”.
3.7
analytical solution
solution prepared prior to measurement by dissolving an analytical portion (3.3) in a liquid material or
dispersing it in a solid material, with or without reaction
3.8
blank
lack of the analyte (3.1) or another component necessary to produce an indication of a measuring system
(3.24) that is specific to the analyte (3.1)
3.9
calibrator
measurement standard (3.22) used in calibration of a measuring system (3.24) according to a specified
measurement procedure (3.21)
Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 5.12 and ISO 17511:2020.
Note 2 to entry: The measurement standard (3.22) should be a certified reference material (3.10), if available.
ISO/DIS 15193:2023(E)
3.10
certified reference material
CRM
reference material (3.31), accompanied by documentation issued by an authoritative body, that provides
one or more specified property values with associated uncertainty (3.41) and traceability using valid
procedures
Note 1 to entry: Documentation is given in the form of a reference material (3.31) certificate and a certification
report.
Note 2 to entry: Requirements for the production and characterization of CRMs are given in ISO 17034 and
ISO 15194 ; guidance on characterization and value assignment is provided in ISO Guide 35.
Note 3 to entry: In this definition, “uncertainty” covers both measurement uncertainty (3.41) and uncertainty
associated with the value of a nominal property, such as for identity or sequence. Traceability covers both
metrological traceability (3.25) of a quantity (3.29) and traceability of a nominal property.
Note 4 to entry: Specified quantity (3.29) values of CRMs require metrological traceability (3.25) with associated
measurement uncertainty (3.41).
Note 5 to entry: ISO 17034 has an analogous definition.
Note 6 to entry: For a specified material, a calibration certificate provided by an accredited calibration laboratory
is not by itself sufficient to confer the status of CRM on these types of materials.
EXAMPLE Human serum with an assigned quantity (3.29) value and associated measurement uncertainty
(3.41) for concentration (amount of substance per unit volume) of cholesterol inherently present in the serum
and used as a calibrator (3.9) or as a trueness control material (3.11) is an example of a CRM.
[SOURCE: ISO 17511: 2020, 3.9]
3.11
control material
substance, material or artefact intended by its producer to be used to verify the performance of a
measurement procedure (3.21)
Note 1 to entry: The control material should be a reference material (3.31), if available.
3.12
detection limit
limit of detection
measured quantity (3.29) value, obtained by a given measurement procedure (3.21), for which the
probability of falsely claiming the absence of a component in a material is β, given a probability α of
falsely claiming its presence
Note 1 to entry: IUPAC recommends default values for α and β equal to 0.05.
Note 2 to entry: The abbreviation LOD is sometimes used.
Note 3 to entry: The term “sensitivity” is discouraged for this concept.
Note 4 to entry: Adapted from ISO/IEC Guide 99:2007, 4.18.
3.13
examination
set of operations having the objective of determining the numerical value, text value or characteristics
of a property
Note 1 to entry: An examination may be the total of a number of activities, observations or measurements
required to determine a value or characteristic.
Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called “quantitative
examinations”; those that determine the characteristics of a property are called “qualitative examinations”.
ISO/DIS 15193:2023(E)
[SOURCE: ISO 15189: 2022, 3.8]
3.14
influence quantity
quantity (3.29) that, in a direct measurement, does not affect a quantity (3.29) that is actually measured,
but affects the relation between the indication and the measurement result
Note 1 to entry: Adapted from ISO/IEC Guide 99:2007, 2.52.
3.15
intermediate precision standard deviation
closeness of agreement between independent test results obtained under stipulated conditions
(ISO 5725-1)
Note 1 to entry: Stipulations can be measurements made at different times, different operators, different
equipment, calibrations carried out between measurements or any combination of those stipulations (from
Table 1 ISO 5725-3:1994)
3.16
laboratory sample
subsample of the primary sample (3.28), as prepared for sending to or as received by the laboratory and
intended for measurement
Note 1 to entry: In cases where there is no subsample of the primary sample (3.28), the primary sample (3.28)
could also be used as the laboratory sample.
3.17
matrix
system matrix
components of a material, except the analyte (3.1)
Note 1 to entry: The biological system excluding the analyte (3.1) is the matrix of the material.
EXAMPLE In the measurand (3.18) “mass concentration of protein in urine”, “urine” is the matrix. In the
measurand (3.18) “amount of substance of glucose in plasma”, “plasma” is the matrix.
[SOURCE: ISO 17511:2020, 3.24]
3.18
measurand
quantity (3.29) intended to be measured
Note 1 to entry: Specification of a measurand requires knowledge of the kind of quantity (3.29), description of the
state of the phenomenon, body, or substance carrying the quantity (3.29), including any relevant component, and
the chemical entities involved.
Note 2 to entry: The measurement, including the measuring system (3.24) and the conditions under which the
measurement is carried out, could change the phenomenon, body, or substance such that the quantity being
measured can differ from the measurand as defined. In this case, adequate correction is necessary.
EXAMPLE The length of a steel rod in equilibrium at ambient Celsius temperature of 23 °C will be different
from the length at the specified temperature of 20 °C, which is the measurand. In this case, a correction is
necessary.
Note 3 to entry: “Analyte” (3.1), or the name of a substance or compound, are terms sometimes used for
“measurand”. This usage is erroneous because these terms do not refer to quantities (3.29).
Note 4 to entry: In laboratory medicine, the description of the measurand includes the name of the quantity
(3.29) (e.g. amount of substance concentration), the component/analyte (3.1) (e.g. β-D-glucose), and the biological
system in which it is found (e.g. blood plasma).
[SOURCE: ISO 17511:2020, 3.26]
ISO/DIS 15193:2023(E)
3.19
measurement interval
set of values of quantities (3.29) of the same kind that can be measured by a given measuring instrument
or measuring system (3.24) with specified instrumental uncertainty (3.41), under defined conditions
Note 1 to entry: The lower limit of a measurement interval should not be confused with limit of detection (3.12).
3.20
measurement method
method of measurement
generic description of a logical organization of operations used in a measurement
[SOURCE: ISO 17511:2020, 3.30]
3.21
measurement procedure
MP
description of a measurement according to one or more measurement principles and to a given
measurement method (3.20), based on a measurement model and including any calculation to obtain a
measurement result. A measurement procedure refers to a written specification for how a measurement
is performed, including a technical description of reagents, calibrators (3.9), equipment, instrument,
and other details necessary to create and operate a measuring system (3.24) that implements those
specifications
Note 1 to entry: A MP is usually documented in sufficient detail to enable an operator to perform a measurement.
Note 2 to entry: A MP can include a statement concerning a target measurement uncertainty (3.41).
Note 3 to entry: A MP is sometimes called a standard operating procedure, abbreviated SOP.
Note 4 to entry: In medical laboratory measurements, a specific instance of a measurement procedure, an IVD
medical device, is used to make a measurement on a clinical sample (3.26) to produce a measurement result
which is used to inform medical decisions for a patient.
[SOURCE: ISO 17511:2020, 3.30 – Note 4 added]
3.22
measurement standard
realization of the definition of a given quantity (3.29), with a stated value and associated measurement
uncertainty (3.41), used as a reference
[SOURCE: ISO 17511:2020, 3.28]
3.23
measurement trueness
trueness of measurement
trueness
closeness of agreement between the average of an infinite number of replicate measured quantity (3.29)
values and a reference quantity (3.29) value
Note 1 to entry: Measurement trueness is not a quantity (3.29) and thus cannot be expressed numerically, but
measures for closeness of agreement are given in ISO 5725.
Note 2 to entry: Measurement trueness is inversely related to systematic measurement error but is not related to
random measurement error.
Note 3 to entry: “Measurement accuracy” should not be used for “measurement trueness”.
[SOURCE: VIM3: 2012, 2.14]
ISO/DIS 15193:2023(E)
3.24
measuring system
set of one or more measuring instruments and often other devices, including any reagent and supply,
assembled and adapted to give information used to generate measured quantity (3.29) values within
specified intervals for quantities (3.29) of specified kinds
Note 1 to entry: A measuring system may consist of only one measuring instrument.
[S OU RC E: V I M3: 2012 , 3.2]
3.25
metrological traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty (3.41)
Note 1 to entry: For this definition, a ‘reference’ can be a definition of a measurement unit through its practical
realization, or a measurement procedure (3.21) including the measurement unit for a quantity (3.29) value, or a
measurement standard (3.22).
Note 2 to entry: Metrological traceability requires an established calibration hierarchy.
Note 3 to entry: The abbreviated term “traceability” is commonly used to refer to other concepts, such as ‘sample
traceability’ or ‘document traceability’ or ‘instrument traceability’ or ‘material traceability’, where the history
(“trace”) of an item is meant. Therefore, the full term of “metrological traceability” is preferred if there is any risk
of confusion.
[SOURCE: ISO 17511:2020, 3.30 –Notes 1, 2 and 9 (here note 3) only are retained from the source]
3.26
precision of measurement
measurement precision
closeness of agreement between indications or measured quantity (3.29) values obtained by replicate
measurements on the same or similar objects under specified conditions
Note 1 to entry: Measurement precision is usually expressed numerically by measures of imprecision, such as
standard deviation, variance, or coefficient of variation under the specified conditions of measurement.
Note 2 to entry: The ‘specified conditions’ can be, for example, repeatability conditions of measurement,
intermediate precision conditions of measurement, or reproducibility conditions (3.35) of measurement (see
ISO 5725-1:1994).
Note 3 to entry: Measurement precision is used to define measurement repeatability, intermediate measurement
precision, and measurement reproducibility.
Note 4 to entry: Sometimes “measurement precision” is erroneously used to mean measurement accuracy.
[SOURCE: ISO/IEC Guide 99:2007, 2.15]
3.27
primary calibrator
primary calibration material
calibrator (3.9) established using a primary reference measurement procedure (3.32), or created as
an artefact, chosen by convention. A primary calibrator serves as the anchor point for a calibration
hierarchy
EXAMPLE 1 Primary calibrator of amount of substance concentration prepared by dissolving a known amount
of substance of a primary reference material (3.31) for a chemical component into a known volume of solution.
EXAMPLE 2 Primary calibrator for isotope amount of substance ratio measurements, prepared by mixing
known amounts-of-substance of specified isotopes.
Note 1 to entry: ISO 17511:2020 further explains the role of a primary calibrator, defined as position m.2 within
a calibration hierarchy.
ISO/DIS 15193:2023(E)
[SOURCE: ISO 17511:2020, 3.37 – with “measurement standard” replaced by “calibrator”, “Note” added
and Examples 1 to 5 in the source text replaced by two examples relevant to laboratory medicine.]
3.28
primary sample
specimen
discrete portion of a body fluid or tissue or other sample associated with the human body taken for
examination (3.13), study or analysis of one or more quantities (3.29) or characteristics to determine
the character of the whole
[SOURCE: ISO 15189:2022, 3.25]
3.29
quantity
property of a phenomenon, body, or substance, where the property has a magnitude that can be
expressed as a number and a reference
+
EXAMPLE 1 “Plasma (Blood) — Na ion; amount of substance concentration of 143 mmol/l in a given person at
a given time”.
EXAMPLE 2 Number concentration of erythrocytes in a blood sample (whole blood) of 5 × 10 /μl in a given
person at a given time.
Note 1 to entry: Quantity is not to be confused with analyte (3.1).
Note 2 to entry: A measurement procedure (3.21) for which the result is expressed in a qualitative manner (e.g.
nucleotide sequence for a DNA sample or “present” or “not present” against a ratio or counting scale with a pre-
determined decision threshold), are consistent with this definition of the term quantity.
[SOURCE: ISO 17511:2020, 3.38]
3.30
recovery
fraction of analyte (3.1) measured as a proportion of the amount of analyte (3.1) present in or added to
the analytical portion (3.3) of the test material, which is presented for measurement after preparation
of the sample
[14]
Note 1 to entry: Cited from and modified.
3.31
reference material
RM
material sufficiently homogeneous and stable with reference to specified properties, which has been
established to be fit for its intended use in measurement or in examination (3.13) of nominal properties
EXAMPLE 1 Examples of RMs embodying a quantity (3.29):
a) water of stated purity, the dynamic viscosity of which is used to calibrate viscometers;
b) human serum without an assigned quantity (3.29) value for the amount of substance concentration
of cholesterol inherently present in the serum and used as a control material (3.11).
EXAMPLE 2 Example of RMs embodying nominal properties:
DNA compound containing a specified nucleotide sequence.
EXAMPLE 3 Spheres of uniform size mounted on a microscope slide.
Note 1 to entry: RMs with or without assigned quantity (3.29) values can be used as control materials (3.11)
whereas only CRMs (3.10) with traceable quantity (3.29) values can be used as calibrators (3.9) or as trueness
control materials (3.11).
Note 2 to entry: RMs normally embody quantity (3.29) values but can also embody nominal properties.
ISO/DIS 15193:2023(E)
Note 3 to entry: RMs can have assigned quantity (3.29) values that are traceable to a measurement unit outside
the International System of units (SI).
Note 4 to entry: An RM accompanied by documentation issued by an authoritative body and referring to valid
measurement procedures (3.21) used to assign a quantity (3.29) value with associated measurement uncertainty
(3.41) and metrological traceability (3.25) is referred to as a CRM (3.10).
[SOURCE: ISO 17511: 2020, 3.39 with modifications]
3.32
reference measurement procedure
RMP
measurement procedure (3.21) accepted as providing measurement results fit for their intended use
in assessing measurement trueness (3.23) of measured quantity (3.29) values obtained from other
measurement procedures (3.21) for a quantity (3.29) of the same kind, in calibration, or in assigning a
quantity (3.29) value to a CRM (3.10)
Note 1 to entry: Definitions of reference materials (3.31) are described in ISO 15194.
Note 2 to entry: Explanation of the role of a primary RMP within a calibration hierarchy can be found in ISO 17511.
Note 3 to entry: When several reference measurement procedures exist for a given measurable quantity (3.29), it
can be possible to arrange them in a hierarchy according to size of measurement uncertainty (3.41).
Note 4 to entry: This document refers to reference measurement procedures in general and includes higher order
reference measurement procedures as defined in ISO 17511:2020.
[SOURCE: ISO 17511:2020, 3.40 – modified]
3.33
reference measurement system
measuring system (3.24) accepted as fit for its intended purpose in assessing or establishing measurement
trueness (3.23) for quantity (3.29) values obtained from other measurement procedures (3.21) for the
measurand (3.18); comprised of (1) a unit of measurement, (2) a definition of the measurand (3.18), (3)
RMP(s), (4) RM(s) and (5) one or more laboratories providing reference measurement services
3.34
repeatability standard deviation
the standard deviation of test results obtained with the same method on identical test items in the
same laboratory by the same operator using the same equipment within short intervals of time
[SOURCE: ISO 5725-1:1994]
3.35
reproducibili
...